Abstract

This study aimed to compare the test results of anti-double-stranded DNA (anti-dsDNA) antibodies obtained using chemiluminescent immunoassay (CIA) and enzyme-linked immunosorbent assay (ELISA), and investigate predictors of inconsistent results. This retrospective study included 502 patients who underwent CIA and ELISA to determine their anti-dsDNA antibody values within a year. We compared the diagnostic power for SLE, disease activity, and predictive power for lupus nephritis (LN). A multivariate analysis was performed to determine the predictors of inconsistencies. CIA and ELISA were moderately correlated in terms of their consistency (Cronbach’s α = 0.571), and yielded comparably favorable results in terms of SLE diagnostic power and SLE disease activity. However, if the patient had LN, CIA displayed higher predictive power than ELISA (0.620 vs. 0.555, p = 0.026). Compared with the CIA/ELISA double-positive group, the inconsistent group had lower anti-C1q circulating immune complexes (CIC) antibody values (OR: 0.42, 95% CI: 0.18–0.94, p = 0.036), and lower SLEDAI scores (≥4) (OR: 0.33, 95% CI: 0.14–0.79, p = 0.013). Anti-dsDNA antibody detection with CIA exhibited higher predictability for diagnosing LN than did ELISA. In the event of inconsistencies between anti-dsDNA methods, SLE disease activity and CIC test values should be considered simultaneously.

Highlights

  • Systemic lupus erythematosus (SLE) is a severe autoimmune disease that produces various antibodies and involves multiple organs [1]

  • Since 1982, anti-double-stranded DNA antibodies have been listed as diagnostic criteria for SLE by the American College of Rheumatology (ACR) [3], and studies have noted a high correlation between anti-dsDNA antibodies and lupus nephritis (LN) [4]

  • The double-positive group had a higher intake rate of hydroxychloroquine, mycophenolic acid, and azathioprine than the double-negative group within 3 months (Table 2). These findings indicated that double-positive results of chemiluminescent immunoassay (CIA) and enzyme-linked immunosorbent assay (ELISA) could effectively distinguish patients with SLE, that the patients’ disease activity was higher than the other two groups, and that they were receiving active treatment

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Summary

Introduction

Systemic lupus erythematosus (SLE) is a severe autoimmune disease that produces various antibodies and involves multiple organs [1]. Anti-dsDNA antibodies are relatively effective indicators for monitoring SLE disease activity [5]. Rheumatologists have relied on anti-dsDNA antibodies to adjust medication and treatment strategies for patients with SLE. Current methodologies for detecting anti-dsDNA antibodies include Farr radioimmunoassay, Crithidia luciliae indirect immunofluorescence test (CLIFT), enzyme-linked immunosorbent assay (ELISA), fluoroenzyme immunoassay (FEIA), and chemiluminescent immunoassay (CIA) [6]. CLIFT involves using the kinetoplast of Crithidia luciliae to form a specific combination with anti-dsDNA antibodies, making it highly specific. CLIFT is limited by qualitative inspections, requires manual interpretation, and is prone to differences due to microscope equipment, making it difficult to be used as a method for disease activity monitoring. ELISA and CIA are preferred for clinical monitoring of disease activity [8,10,11]

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